| CTRI Number |
CTRI/2024/11/076152 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Satvavajaya Chikitsa (Counselling therapy), Bhramari Pranayama versus Brahmi Ghrita in Depression(Vishada) |
|
Scientific Title of Study
|
Assessment of add-on effect of Satvavajaya Chikitsa (Counselling), Bhramari Pranayama versus Brahmi Ghrita in Vishada (Depression)- A three-arm Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikas Chaurasiya |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research center Salod (H) Wardha Maharashtra |
| Address |
Department of Samhita and Siddhant Division- 2 Room no- 22,
Mahatma Gandhi Ayurveda College Hospital and
Research center Salod (H) Wardha Maharashtra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9044855217 |
| Fax |
|
| Email |
chaurasiyavik123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dnyanesh Joshi |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved college hospital and research centre Salod (H) Wardha Maharashtra |
| Address |
Department of Samhita and Siddhant Division- 2 Room no- 22,
Mahatma Gandhi Ayurved college hospital and
research centre Salod (H) Wardha Maharashtra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8087374390 |
| Fax |
|
| Email |
dnyanesh.joshi@dmimsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dnyanesh Joshi |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved college hospital and research centre Salod (H) Wardha Maharashtra |
| Address |
Department of Samhita and Siddhant Division- 2 Room no- 22,
Mahatma Gandhi Ayurved College Hospital and
research centre Salod (H) Wardha Maharashtra
442001
INDIA
Wardha
MAHARASHTRA
442001
India |
| Phone |
8087374390 |
| Fax |
|
| Email |
dnyanesh.joshi@dmimsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved college hospital and
research centre Salod (H) Wardha Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Vikas Chaurasiya |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod (H) Wardha Maharashtra Pin - 442001 India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikas Chaurasiya |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra |
Room no. 30, Department of Kayachikita, Mahatma Gandhi Ayurved Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Wardha
MAHARASHTRA |
9044855217
chaurasiyavik123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGACH&RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F430||Acute stress reaction. Ayurveda Condition: VISHADAH/DINATAÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: BRAHMI GHRITA, Reference: CHARAK SAMHITA, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 24 Days, anupAna/sahapAna: Yes(details: -Leuk warm water), Additional Information: - | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: BHRAMARI PRANAYAMA , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:COUNSELLING (SATVAVAJAYA CHIKITSA) , Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1-Patient willing for written informed consent to participate in the study.
2-Patient between the age group of 16 to 40 years of either gender.
3-Patient with BDI score between 21-30.
4--Patient having symptom of Vishada (Depression).
|
|
| ExclusionCriteria |
| Details |
1-Severe patients of Depression having BDI score more than 30.
2-Pregnant and lactating women.
3-Known case of CKD, CLD, CAD & Cancer
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Hamilton score and BDI scale |
24 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1- To evaluate the add-on effect of Satvavajaya Chikitsa (Counselling) & Brahmi Ghrita in Vishada(Depression)
2- To evaluate the add-on effect of Bhramari Pranayam & Brahmi Ghrita in Vishada(Depression)
3- To evaluate the efficacy of only Brahmi Ghrita in Vishada(Depression).
4- To compare the efficacy of Satvavajaya Chikitsa (Counselling) Bhramari Pranayam & Brahmi Ghrita in Vishada(Depression) |
24 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients Patient willing for written informed consent to participate in the study. Patient between the age group of 16 to 40 years of either gender. Patient with BDI score between 11 to 20. Patient having symptom of Vishada (depression). Patients will be recruited from the OPD and IPD of all the department of MGACH & RC, AVBRH, Salod (H) Wardha and from specialty peripheral camps |